1. Field of the Invention
The present invention relates to an immunoblot enzyme immuno transferable assay useful for diagnosing human cysticercosis.
2. Background of the Invention
Human cysticercosis is a potentially fatal invasion of various tissues by the larvae of Taenia solium. The disease has increased dramatically in prominence as a medical problem in the United States since 1977. Increased travel and immigration from highly endemic areas such as Mexico and Central America make recognition and treatment of cysticercosis a U.S. public health priority. The impetus to develop a more sensitive and specific immunodiagnostic test for human cysticercosis, was provided by the increasing demands for a confirmatory assay to support clinical and radiological findings and by the effectiveness of Praziquantel for the treatment of cysticercosis.
Previous efforts to improve serodiagnostic assays have concentrated on the ELISA (enzyme-linked immunoabsorbent assay), IHA (indirect hemagglutinatino assay), and RIA (radioimmmunoassay) formats. Claimed test efficacy for these assays ranged from 67%-100% specificity and 47%-95% sensitivity. Many reports, however, based their claims on relatively low serum sample numbers, and frequency of cross-reactivity from heterologous infections, such as Echinococcus spp., was not addressed. In general, the prior art seriologic assays for human cysticercosis lack either specificity or sensitivity, or in some cases both specificity and sensitivity.
U.S. Pat. No. 4,740,456 discloses an immunological method for diagnosing neurocysticercosis which involves detecting antigens of larval origin. The antigens to be assayed are selected from those antigens identified having molecular weights of 64K, 53K and 30-32K. daltons as determined by sodium dodecyl polyacrylamide gel electophoresis (SDS-PAGE). The preferred method of antigen detection is by way of the ELISA method. The method to date has not been utilized in the diagnosis of neurocysticercosis due to its many drawbacks such as lack of sensitivity and specificity.
With respect to the kit utilized in the diagnosis, of the Kuhn patent, i.e., the disc method, reaction with one particular antigen cannot be distinguished from that of the other antigens. Furthermore, the discs are only antigen coated and thus the antigens are not tightly bound to the disc. The above disadvantages result in a loss of specificity and sensitivity of the diagnosis. The present invention has been accomplished with the above disadvantages in mind.